EASE SBS 6
Research type
Research Study
Full title
A 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of Glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.
IRAS ID
1013008
Contact name
Anette Bjärdahlen
Contact email
Sponsor organisation
Zealand Pharma A/S
Research summary
The main purpose of this trial is to evaluate long-term safety of glepaglutide in patients with Short bowel syndrome (SBS).
SBS is a condition where a person is missing a part of the small and/or large intestine, or it is damaged. This can happen because they had a large part of their intestines removed in surgery or because they were born with certain diseases. The patient has too little bowel to absorb the required fluid and nutrients from their food and other intake to survive. Parenteral support (PS) in the form of liquids is given directly into the bloodstream to maintain nutrition and hydration. Glepaglutide is a new medicine, which is being developed for the treatment of SBS and is taken twice a week. It comes in a ready-to-use auto-injector, lowering the risk of dosing errors and improving adherence to the prescribed treatment. Glepaglutide is not approved by the authorities. However, in clinical trials, it has been shown to improve bowel function and thereby reduce the need for PS.
The trial doctors will monitor how well the participants in this trial tolerate the medicine and identify any potential side effects. They will also investigate how treatment with glepaglutide affects patients with SBS by measuring changes in weekly PS volume. The trial will include patients with SBS who are being actively treated and have completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial or are actively treated in the EASE SBS 3 trial. As the EASE SBS 2 and EASE SBS 3 trials are ending earlier than planned, this trial will provide patients with an opportunity to continue their treatment with glepaglutide to ensure continued care.REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0351
Date of REC Opinion
18 Dec 2025
REC opinion
Further Information Favourable Opinion